顶空气相色谱法测定医疗注射器械中环氧乙烷的残留量

目的探讨应用顶空气相色谱测定法测定医疗注射器械中的环氧乙烷浓度。方法HP-5色谱柱（30m×250μm×0．25μm）分离，氢火焰离子化检测器（FID）检测，柱温为120℃，保持8min：进样口温度为200℃检测器温度为250℃。结果环氧乙烷在5～50μm范围内呈线性关系，相关系数r=0．994，最低检出浓度为1μg／g；相对标准偏差为1．7％-5．6％。结论该方法灵敏度、准确度均达到有机溶剂残留量测定的要求，可用于输液器、注射器中环氧乙烷残留量的测定。

Determination of Residual Epoxyethane in Medical Injection Instruments by Headspace Capillary Gas Chromatography

Objective To explore the determination of residual epoxyethane in medical injection instruments using headspace capillary gas chromatography.Methods An HP-5 capillary column(30 m×250 μm×0.25 μm) and an FID detector were used in the determination.The oven temperature was kept at 120 ℃ for 8 minutes.The example inlet temperature was kept at 200 ℃,while the temperature of the detector was kept at 250 ℃.Results The method had a linear range between 5~50 μg(r=0.994).The detection limit was 1 μg/g,and the standard deviations were 1.7%~5.6%.Conclusions The method has been proved to be convenient,sensitive and accurate.It meets the requirement for the determination of residual epoxyethane in medical injection instruments.